TSDR Pharmacy Inc. dba brandMD Skin Care

CLOSEOUT LETTER TSDR Pharmacy Inc. dba brandMD Skin Care MARCS-CMS 540960 — April 29, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Cosmetics Drugs Recipient: Recipient Name Samuel D. Raoof Recipient Title CEO and President TSDR Pharmacy Inc. dba brandMD Skin Care 20660 Nordhoff Street Chatsworth , CA 91311-6114 United States Issuing Office: Center for Drug Evaluation and Research 19701 Fairchild Irvine , CA 92612-2506 United States 949-608-2900 Dear Mr. Raoof: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter dated November 9, 2017. We acknowledge that your California state-issued pharmacy license (PHY 50543) has been cancelled and that your facility is closed. If you decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to resuming drug production. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 05/07/2019 Regulated Product(s) Cosmetics Drugs